The FDA approved Kentucky-based US WorldMeds Lucemyra (lofexidine hydrochloride) for the mitigation of opioid withdrawal symptoms in adults. Lucemyra, an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, was reviewed by the FDA under a priority review. Approval for the treatment was based on positive trial data that showed the medication significantly reduced the severity of withdrawal symptoms in comparison to placebo. The medication was approved for use for up to two weeks, the FDA said. Compared to placebo in two Phase III trials, US WorldMeds said participants treated with Lucemyra experienced less severe withdrawal symptoms and were significantly more likely to complete a seven-day opioid discontinuation treatment.

P. Breckinridge Jones, chief executive officer and founder of US WorldMeds said Lucemyra provides new hope for people who are struggling with the “agonizing symptoms” of opioid withdrawal.

“We are humbled to bring to market the first and only non-opioid treatment for the mitigation of withdrawal symptoms – and are grateful for the urgency demonstrated by the FDA in rapidly reviewing and approving this important treatment,” Jones said in a statement.

FDA Commissioner Scott Gottlieb said his agency is dedicated to encouraging innovative approaches that will “help mitigate the physiological challenges” associated with opioid withdrawal. Symptoms associated with opioid withdrawal include anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and a craving for the drug. Gottlieb said the FDA is in the process of developing a new guidance to help accelerate the development of treatments that can help curb addition.

“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms. The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that’s sometimes associated with the use of medication-assisted treatments,” Gottlieb said in a statement.

US WorldMeds anticipates it can have its opioid withdrawal medication available to help patients by August. As part of the approval, the FDA said it will require 15 postmarketing studies, including both animal and human studies to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children.